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Differences in the EU regulations for biomedical research on humans and animals: an ethical analysis. 欧盟对人类和动物生物医学研究规定的差异:伦理分析。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-05-08 DOI: 10.1007/s11019-025-10270-x
Katarzyna Żebrowska

The European Union regulations for research on human and nonhuman participants differ significantly. This study aims to present a thorough analysis of these differences in the field of biomedical research. The study consists of a review of regulations issued by the European Union and Council of Europe institutions, supported by two UNESCO documents. The regulations are compared between three types of research: on humans, on nonhuman animals, and research using human embryos, within five categories: (1) Justification and scope of the regulations; (2) Inclusion criteria; (3) Consent procedures; (4) Participants' welfare; and (5) Values in research. In each category, significant differences between regulations for humans and animals are presented. These differences can be ethically analyzed in terms of values pursued in the protection of participants (intrinsic value of humans vs. value of animal welfare) and hierarchies of values in regulations (priority of participant-centered values in research on humans vs. priority of research-centered values in research on animals). Since the current protection of animals in biomedical research based on the '3Rs' principles seems not adequate, two possible ways forward are analyzed: replacement of all animals in research with other methods and a shift to research on companion animals.

欧盟对人类和非人类参与者的研究规定有很大不同。本研究旨在对生物医学研究领域的这些差异进行全面分析。这项研究包括审查欧洲联盟和欧洲理事会各机构发布的条例,并得到教科文组织两份文件的支持。对人类研究、非人类动物研究和利用人类胚胎研究三种研究类型进行了比较,分为五类:(1)法规的依据和范围;(2)入选标准;(3)同意程序;(4)参与者福利;(5)研究价值。在每个类别中,人类和动物的法规之间存在显著差异。这些差异可以从保护参与者所追求的价值观(人类的内在价值与动物福利的价值)和法规中的价值观等级(人类研究中以参与者为中心的价值观优先与动物研究中以研究为中心的价值观优先)两方面进行伦理分析。鉴于目前基于“3r”原则的生物医学研究中对动物的保护似乎不够充分,本文分析了两种可能的前进道路:用其他方法替代所有动物研究和转向伴侣动物研究。
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引用次数: 0
Consent and its discontents: the case of UK Biobank. 同意及其不满:英国生物银行案例。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-07-17 DOI: 10.1007/s11019-025-10276-5
Gulzaar Barn

UK Biobank is a major biomedical database and research resource, holding the genetic, health, and lifestyle information of half a million adult volunteers. Its datasets are accessible to approved researchers from academic, charity, government, and commercial organisations for health-related research in the public interest. Drawing upon a range of approved projects and the downstream applications of this research, I suggest that UK Biobank datasets have been processed towards ends that are inimical to its stated aims, breaking the terms of consent under which its participants entered the study. First, I provide an overview of the broad consent model employed by UK Biobank in recruiting participants and using their data. The consent documents and participant information leaflets used exhibit information failures in their framing of health-research in terms of disease and treatment, obscuring the full range of lawful uses of participants' data. Beyond this, certain approved uses of UK Biobank data, including studies by insurance companies and direct-to-consumer genetic testing companies, arguably fall outside UK Biobank's stated aims altogether. Moreover, UK Biobank has not adequately safeguarded against "dual use" issues. Tracking the trajectory of research outputs that used biobank data, I suggest that approved uses of biobank datasets have gone on to have objectionable further applications that are not in the public interest. Such applications include the development of polygenic scores that seek to predict "intelligence" for use in commercial embryo screening services. Such tools are rife with risk of harm and are being deployed without sufficient public deliberation or oversight.

英国生物银行是一个主要的生物医学数据库和研究资源,拥有50万成年志愿者的遗传、健康和生活方式信息。其数据集可供学术、慈善机构、政府和商业组织的经批准的研究人员使用,以进行与公共利益相关的研究。根据一系列已批准的项目和本研究的下游应用,我认为UK Biobank数据集已被处理到与其既定目标背道而驰的目的,违反了参与者进入研究时的同意条款。首先,我概述了英国生物银行在招募参与者和使用他们的数据时采用的广泛同意模型。所使用的同意文件和参与者信息传单显示,从疾病和治疗的角度界定健康研究的信息存在缺陷,模糊了参与者数据合法使用的全部范围。除此之外,英国生物银行数据的某些批准用途,包括保险公司和直接面向消费者的基因检测公司的研究,可以说完全超出了英国生物银行的既定目标。此外,英国生物银行没有充分防范“双重用途”问题。通过跟踪使用生物样本库数据的研究成果的轨迹,我认为,生物样本库数据集的批准使用已经继续产生不符合公众利益的令人反感的进一步应用。这些应用包括开发多基因评分,旨在预测用于商业胚胎筛选服务的“智力”。这些工具充满了伤害的风险,并且在没有充分的公众审议或监督的情况下部署。
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引用次数: 0
Menstrual pain and epistemic injustice. 经期疼痛和认知不公。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-04-05 DOI: 10.1007/s11019-025-10266-7
Adriana Joanna Mickiewicz

In this paper I analyze the phenomenon of normalizing and tabooing menstrual pain as an example of epistemic injustice. I refer to both types of epistemic injustice distinguished by Miranda Fricker: testimonial injustice and hermeneutic injustice. The social approach to the phenomenon of menstrual pain combines both. This poses a significant political and bioethical problem, as ignoring and misunderstanding the experiences of menstrual pain sufferers can contribute to delayed diagnosis and reinforce patients' sense of loneliness.

在本文中,我分析了正常化和禁忌月经疼痛的现象,作为认识不公正的一个例子。我指的是由米兰达·弗里克(Miranda Fricker)区分的两种类型的认识论的不公正:证言的不公正和解释性的不公正。社会对经期疼痛现象的看法将两者结合起来。这带来了一个重大的政治和生物伦理问题,因为忽视和误解经期疼痛患者的经历可能导致诊断延误,并加剧患者的孤独感。
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引用次数: 0
Integrating ethics in digital mental healthcare technologies: a principle-based empirically grounded roadmap approach. 整合伦理在数字精神卫生保健技术:基于原则的经验为基础的路线图方法。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-07-30 DOI: 10.1007/s11019-025-10283-6
Wanda Spahl, Giovanni Rubeis

Digital mental healthcare technologies increasingly incorporate gamification, yet relevant ethical considerations remain underexamined. This paper introduces the Principle-Based Empirically Grounded Roadmap Approach (PERA), a methodological contribution to empirical bioethics. It has evolved from ethics research within the Horizon Europe project ASPbelong, which designs a collaboratively played augmented reality intervention for adolescents. PERA refines existing integrated empirical bioethics methodologies by responding to three key characteristics of the use case: a largely predetermined technology with a relatively low degree of openness in technological design, embedded co-development practices led by facilitators from within the project team, and planned future iterations beyond the ethics team's involvement. PERA integrates mapping of principles from the ethics literature, a scoping review of the moral intuitions of developers of comparable technologies, and the collection of original empirical data on the use case. Using abductive reasoning, these insights are synthesized into a tangible output: an ethics roadmap designed to guide and be adapted in future use case iterations. By advancing a methodology of combining normative reasoning with empirical insights on a concrete use case, this paper provides both practical tools for ethics researchers in technology projects and a means to generate empirically grounded conceptual contributions. Its outcomes, when brought into dialogue with findings from other integrated empirical bioethics research, can support the critical examination of broader assumptions and implications of gamified mental healthcare, including questions of good care and the broader social implications of such technologies.

数字精神保健技术越来越多地融入游戏化,但相关的伦理考虑仍未得到充分审查。本文介绍了基于原则的经验基础路线图方法(PERA),这是对经验生物伦理学的方法论贡献。它是从地平线欧洲项目ASPbelong的伦理研究演变而来的,该项目为青少年设计了一种协作式的增强现实干预。PERA通过响应用例的三个关键特征来改进现有的集成经验生物伦理学方法:在技术设计中具有相对较低程度的开放性的主要预先确定的技术,由项目团队内部的促进者领导的嵌入式共同开发实践,以及超出伦理团队参与的计划未来迭代。PERA集成了来自伦理文献的原则映射,对可比技术开发人员的道德直觉的范围审查,以及对用例的原始经验数据的收集。使用溯因推理,这些见解被合成为有形的输出:设计用于指导和适应未来用例迭代的道德路线图。通过提出一种将规范推理与具体用例的经验见解相结合的方法,本文为技术项目中的伦理学研究人员提供了实用工具,并提供了一种产生经验基础概念贡献的方法。当将其结果与其他综合经验生物伦理学研究的结果进行对话时,可以支持对游戏化精神保健的更广泛假设和影响进行批判性审查,包括良好护理问题和此类技术的更广泛社会影响。
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引用次数: 0
Phenomenology and ethics of terminal pain. Cicely Saunders' proposal. 晚期疼痛的现象学与伦理学。Cicely Saunders的提议。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-05-03 DOI: 10.1007/s11019-025-10273-8
Ilaria Malagrinò

Differently from pre-technological societies, the contemporary one, when faced with pain, always thinks it can prepare a therapeutic response using the technique as the most valid form to dominate it. However, medicalization and pharmacology of pain prevent it from becoming language. Thus, medical progress makes men much more vulnerable to pain. If, on the one hand, the benefits of anesthesia constitute an unparalleled achievement, on the other, they generate a sense of indifference to life. This is precisely why it is important and urgent to return to listening to the cry of pain. In this sense, particularly commendable were the efforts of Cicely Saunders, who dedicated her entire life to listening to pain and made listening to pain the cornerstone of the philosophy of the Hospice Movement. Therefore, this paper aims to propose a reconstruction of the phenomenology of terminal pain that emerges in Cicely's writings, highlighting its particularity and usefulness in designing a better approach to pain management. Terminal pain has a strong ethical dimension that requires not only a therapeutic but, above all, an ethical response. The proposal of care that derives from Saunders' reflections focuses on the direct encounter with the other caught in its aspect of contact and restores importance to the medical art imagined as "pathic," which, based on a complete or comprehensive wisdom, surpasses the classical humanistic vision and dichotomy which separates it from the purely biomedical one.

与前技术社会不同,当代社会在面对痛苦时,总是认为它可以准备一种治疗反应,利用技术作为最有效的形式来支配它。然而,疼痛的医学化和药理学阻止它成为语言。因此,医学的进步使男性更容易受到疼痛的伤害。一方面,麻醉的好处构成了一项无与伦比的成就,另一方面,它们产生了一种对生命的冷漠感。这正是恢复倾听痛苦的呼声的重要性和紧迫性的原因。从这个意义上说,尤其值得赞扬的是Cicely Saunders的努力,她一生致力于倾听痛苦,并将倾听痛苦作为临终关怀运动哲学的基石。因此,本文旨在对Cicely著作中出现的晚期疼痛现象学进行重建,强调其特殊性和在设计更好的疼痛管理方法方面的有用性。晚期疼痛具有强烈的伦理维度,不仅需要治疗,而且最重要的是,需要伦理回应。从桑德斯的反思中衍生出来的关怀的建议,聚焦于与他者的直接接触,并恢复了被想象为“悲情”的医学艺术的重要性,它基于一种完整或全面的智慧,超越了将其与纯粹的生物医学区分开来的经典人文主义视野和二分法。
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引用次数: 0
The role of clinicians in the looping effect: epistemic injustices and looping breaks. 临床医生在循环效应中的作用:认知不公与循环断裂。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-06-09 DOI: 10.1007/s11019-025-10279-2
Christophe Gauld, Boris Nicolle, Axel Constant, Anne-Marie Gagné-Julien

The debate on whether psychiatric disorders can be studied as natural kinds has raised controversy, reviving socio-constructionist arguments about the influence of social factors on psychiatric categories. A key concept in this discussion is the "looping effect", which describes how individuals change in response to their classifications, necessitating revisions to those classifications. We argue that, until now, the broad discussions around the looping effect have greatly failed to integrate the perspectives surrounding clinicians and patients. We examine more closely the dynamic and unstable nature of psychiatric diagnoses by proposing two key hypotheses: first, that understanding the looping effect requires incorporating both clinician and patient viewpoints, and that when done adequately, such an incorporation can facilitate the work of the clinician by creating feedback loops (i.e., the iterative adjustment of clinical interpretations based on patient responses); and second, that epistemic injustices between clinicians and patients can create disruptions in these feedback loops, which we call "looping breaks", rendering them ineffective. Looping breaks can happen at the clinical level of the relationship between the patient and the clinician or at the nosological level (during the process of revising a classification). We suggest that looping breaks can be caused by a denial or minimization of credibility based on identity prejudice, or due to an epistemic disadvantage, affecting the experiential feedback of patients following the announcement of a diagnosis. To substantiate our claims, we first examine the impact of looping effects in the interaction between patients and clinicians. Second, we investigate the impact of these interactions at the nosological level, on the broader diagnostic framework. We identify epistemic injustices as critical factors that can lead to looping breaks at both levels, thus affecting the stability and validity of psychiatric diagnoses. Our findings underscore the importance of an epistemic approach to the looping effect, emphasizing both knowledge validity and justice in clinician-patient relationships and among clinicians themselves.

关于精神疾病是否可以作为自然类型进行研究的争论引起了争议,重新引发了社会建构主义关于社会因素对精神疾病类别影响的争论。这个讨论中的一个关键概念是“循环效应”,它描述了个体如何根据他们的分类而变化,从而需要对这些分类进行修订。我们认为,到目前为止,围绕循环效应的广泛讨论在很大程度上未能整合围绕临床医生和患者的观点。我们通过提出两个关键假设来更仔细地研究精神诊断的动态和不稳定性:首先,理解循环效应需要结合临床医生和患者的观点,如果做得充分,这种结合可以通过创建反馈循环(即,基于患者反应的临床解释的迭代调整)来促进临床医生的工作;第二,临床医生和病人之间认知上的不公正会破坏这些反馈回路,我们称之为“循环中断”,使它们失效。循环中断可能发生在临床层面的患者和临床医生之间的关系,也可能发生在分类学层面(在修订分类的过程中)。我们认为,循环中断可能是由基于身份偏见的否认或最小化可信度引起的,或者是由于认知上的劣势,在宣布诊断后影响患者的经验反馈。为了证实我们的说法,我们首先检查了患者和临床医生之间互动中循环效应的影响。其次,我们研究了这些相互作用在病分学水平上对更广泛的诊断框架的影响。我们认为认知上的不公正是导致这两个层面的循环中断的关键因素,从而影响了精神病学诊断的稳定性和有效性。我们的研究结果强调了认知方法对循环效应的重要性,强调了临床医患关系和临床医生之间知识的有效性和公平性。
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引用次数: 0
A normativity mapping review on end-of-life care in long-term care institutions by authors from Germany, Austria, and Switzerland. 来自德国、奥地利和瑞士的作者对长期护理机构临终关怀的规范性映射回顾。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-09-01 Epub Date: 2025-06-06 DOI: 10.1007/s11019-025-10278-3
Ingrid Metzler, Hanna Mayer, Giovanni Rubeis, Jasmin Eppel-Meichlinger

This article presents the findings of a "normativity mapping review" designed to make visible the breadth of normative understandings at work within interdisciplinary scholarship on end-of-life care in long-term care institutions. The scope of the literature was limited to peer-reviewed articles authored by scholars affiliated with institutions in Austria, Germany, and Switzerland. Terms and slogans associated with the hospice movement were used as keywords to search for literature in both German and English. During data analysis, values, frameworks, and actions were systematically extracted from the articles. Actions were then clustered into four groups: one involving actions aimed at planning future end-of-life decision-making; another focused on transforming cultures of care; a third encompassing end-of-life practices; and a fourth consisting of residual actions. A comparison of two of these groups shows that normative understandings of end-of-life care in long-term care institutions take shape around two poles-a procedural pole, involving standardised tools that can be used in specific practices to address challenges and improve care, and a substantive pole, centred on the embodied competencies and moral sensibilities of caregivers in realising visions of good end-of-life care.

本文介绍了一项“规范性映射审查”的发现,旨在使长期护理机构的临终关怀跨学科学术研究中工作的规范性理解的广度可见。文献范围仅限于奥地利、德国和瑞士机构的学者撰写的同行评议文章。与临终关怀运动相关的术语和口号被用作搜索德语和英语文献的关键词。在数据分析过程中,系统地从文章中提取价值、框架和行动。然后将行动分为四组:一组涉及旨在规划未来临终决策的行动;另一个重点是改变护理文化;第三种包括临终实践;第四种是残留作用。对其中两个群体的比较表明,对长期护理机构中临终关怀的规范理解围绕两个极点形成——一个是程序极点,涉及可用于具体实践的标准化工具,以应对挑战和改善护理;一个是实质性极点,集中在实现良好临终关怀愿景的护理人员的具体能力和道德敏感性上。
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引用次数: 0
Compassion in the justification of physician-assisted dying: Gandhi's non-violence vs. Aristotle's virtues and vices. 为医生协助下的死亡辩护时的同情:甘地的非暴力与亚里士多德的美德与罪恶。
IF 2.3 2区 哲学 Q1 ETHICS Pub Date : 2025-06-01 Epub Date: 2025-01-29 DOI: 10.1007/s11019-025-10251-0
Ercan Avci

Compassion is an essential phenomenon in the therapeutic relationship, and some use it to justify physician-assisted dying practices. The value of compassion in the relationship between healthcare professionals and patients is undeniable. However, different approaches to its definition and scope can lead to distinct conclusions about the role of compassion in end-of-life interventions. In this context, the paper aims to compare Mahatma Gandhi's and Aristotle's views on compassion to explore whether it can be utilized to justify physician-assisted dying. Gandhi's thoughts on compassion and Aristotle's standpoint on virtues and vices demonstrate that Gandhi evaluates this concept as a moral duty to relieve intractable suffering, whereas Aristotle relies on balancing all virtues through relevant deficiencies and excesses. Therefore, even though Gandhi's opinion on compassion can for allow assisted dying interventions, Aristotle's idea of virtues and vices restricts compassion to a scope that alleviates suffering through available means without causing death.

同情是治疗关系中的一个基本现象,有些人用它来证明医生协助死亡的做法是正当的。在医护人员和病人之间的关系中,同情心的价值是不可否认的。然而,对其定义和范围的不同方法可能导致关于同情在临终干预中的作用的不同结论。在此背景下,本文旨在比较圣雄甘地和亚里士多德对同情的看法,以探讨是否可以利用它来证明医生协助死亡的合理性。甘地关于同情的思想和亚里士多德关于美德与罪恶的立场表明,甘地将同情的概念视为一种减轻难以解决的痛苦的道德责任,而亚里士多德则依赖于通过相关的不足和过度来平衡所有美德。因此,尽管甘地关于同情的观点可以允许辅助死亡干预,但亚里士多德关于美德和罪恶的观点将同情限制在通过可用手段减轻痛苦而不会导致死亡的范围内。
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引用次数: 0
The need for epistemic humility in AI-assisted pain assessment. 人工智能辅助疼痛评估需要认识上的谦逊。
IF 2.3 2区 哲学 Q1 ETHICS Pub Date : 2025-06-01 Epub Date: 2025-03-15 DOI: 10.1007/s11019-025-10264-9
Rachel A Katz, S Scott Graham, Daniel Z Buchman

It has been difficult historically for physicians, patients, and philosophers alike to quantify pain given that pain is commonly understood as an individual and subjective experience. The process of measuring and diagnosing pain is often a fraught and complicated process. New developments in diagnostic technologies assisted by artificial intelligence promise more accurate and efficient diagnosis for patients, but these tools are known to reproduce and further entrench existing issues within the healthcare system, such as poor patient treatment and the replication of systemic biases. In this paper we present the argument that there are several ethical-epistemic issues with the potential implementation of these technologies in pain management settings. We draw on literature about self-trust and epistemic and testimonial injustice to make these claims. We conclude with a proposal that the adoption of epistemic humility on the part of both AI tool developers and clinicians can contribute to a climate of trust in and beyond the pain management context and lead to a more just approach to the implementation of AI in pain diagnosis and management.

鉴于疼痛通常被理解为一种个体的主观体验,医生、病人和哲学家都很难对疼痛进行量化。测量和诊断疼痛的过程往往是一个令人担忧和复杂的过程。在人工智能的帮助下,诊断技术的新发展有望为患者提供更准确、更有效的诊断,但众所周知,这些工具会复制并进一步加剧医疗保健系统中存在的问题,例如患者治疗不良和系统性偏见的复制。在本文中,我们提出的论点是,在疼痛管理设置中,这些技术的潜在实施存在几个伦理认知问题。我们利用关于自信、认知和证言不公正的文献来提出这些主张。我们的结论是,人工智能工具开发人员和临床医生在认知上的谦逊,可以为疼痛管理环境内外的信任氛围做出贡献,并导致在疼痛诊断和管理中实施人工智能的更公正的方法。
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引用次数: 0
Silence as epistemic agency in mania. 沉默是狂热的认知媒介。
IF 3.1 2区 哲学 Q1 ETHICS Pub Date : 2025-06-01 Epub Date: 2025-01-29 DOI: 10.1007/s11019-025-10256-9
Dan Degerman

Silence is a byword for socially imposed harm in the burgeoning literature on epistemic injustice in psychiatry. While some silence is harmful and should be broken, this understanding of silence is untenably simplistic. Crucially, it neglects the possibility that silence can also play a constructive epistemic role in the lives of people with mental illness. This paper redresses that neglect. Engaging with first-person accounts of mania, it contends that silence constitutes a crucial form of epistemic agency to people who experience mania and that the prevailing failure to recognise this may harm them. The paper proceeds as follows. After briefly examining the negative understanding of silence in the epistemic injustice literature, it outlines three epistemically agential silences: communicative silence, listening silence, and withholding silence. It then deploys these concepts to explore how the ability to perform epistemically agential silence is impaired in mania and why such silences are vital to people. The penultimate section highlights two ways that the failure to recognise the epistemic value of silence can harm people with mania. The paper concludes by drawing out implications for future research on epistemic injustice in psychiatry.

在精神病学知识不公正的新兴文献中,沉默是社会强加伤害的代名词。虽然有些沉默是有害的,应该打破,但这种对沉默的理解过于简单化是站不住脚的。至关重要的是,它忽略了一种可能性,即沉默也可以在精神疾病患者的生活中发挥建设性的认知作用。本文纠正了这种忽视。通过对躁狂的第一人称描述,该书认为沉默构成了躁狂患者的一种重要的认知代理形式,而普遍未能认识到这一点可能会伤害他们。本文的工作如下。在简要考察了认识论不公正文献中对沉默的消极理解之后,它概述了三种认识论代理沉默:交流沉默、倾听沉默和保留沉默。然后运用这些概念来探索在躁狂中执行认知代理沉默的能力是如何受损的,以及为什么这种沉默对人们至关重要。倒数第二部分强调了两种方式,即未能认识到沉默的认知价值可能会伤害躁狂患者。论文的结论是对精神病学认知不公正的未来研究提出了启示。
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引用次数: 0
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